Embolization device and a method of using the same

ABSTRACT

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/990,666, filed Jan. 7, 2016, which is a continuation of U.S.application Ser. No. 14/657,888, filed Mar. 13, 2015, now issued U.S.Pat. No. 9,629,636, which is a continuation of U.S. application Ser. No.14/058,986, filed Oct. 21, 2013, now issued U.S. Pat. No. 9,005,235,which is a continuation of U.S. application Ser. No. 13/569,348, filedAug. 8, 2012, now issued U.S. Pat. No. 8,562,636, which is a divisionalof U.S. application Ser. No. 12/340,483, filed Dec. 19, 2008, now issuedU.S. Pat. No. 8,262,686, which is a continuation of U.S. applicationSer. No. 10/293,139, filed Nov. 12, 2002, now issued U.S. Pat. No.7,481,821, each of which are incorporated by reference herein in theirentireties.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to a device for filling and/orstabilizing the void within an anatomical organ of the body,particularly within the vasculature, and methods for making and usingthe device.

2. Description of the Related Art

An aneurysm is an abnormal dilatation of a biological vessel. Aneurysmscan alter flow through the affected vessel and often decrease thestrength of the vessel wall, thereby increasing the vessel's risk ofrupturing at the point of dilation or weakening. FIG. 1 illustrates anabdominal aorta 2 with a sacular aneurysm 4 having an aneurysm wall 6.FIG. 2 illustrates the abdominal aorta 2 with a vascular prosthesis 8implanted to treat the aneurysm 4, a common aneurysm therapy. Vasculargrafts and stent-grafts (e.g., ANEURX® Stent Graft System from MedtronicAVE, Inc., Santa Rosa, Calif.) are examples of vascular prostheses usedto treat aneurysms by reconstructing the damaged vessel.

With the prosthesis 8 implanted, an aneurysm sac 10 is defined by thevolume between the prosthesis 8 and the aneurysm wall 6. The sac 10 isoften filled, partially or completely, with thrombi 12. The thrombi 12can be partially removed prior to deploying the prosthesis 8. Whetherthe thrombi 12 are removed, gaps exist between the remaining thrombi 12or the aneurysm wall 6 and the prosthesis 8, and even when thrombus ispresent, it can be soft and non-structural. The prosthesis 8 candislodge or migrate due to the poor fit caused by these gaps andshrinkage of the sac 10 that occurs after the implantation of theprosthesis 8, either acutely due to sizing issues, or over time due toreformation of the sac 10. To reduce the risk of prosthesis dislodgementand migration, the sac 10 can be filled to stabilize the anatomyadjacent to the prosthesis 8 resulting in better efficacy of theprosthetic treatment.

A sac filler, or stabilizer, can be introduced to the sac 10 bytrans-graft, trans-collateral, trans-sac, or endoluminal procedures. Thetrans-graft procedure introduces the sac filler through an opening inthe prosthesis 8, as shown by arrows 12. The trans-collateral procedure,shown by arrows 16, introduces the sac filler through a collateralvessel 18 under fluoroscopic guidance that is in direct communicationwith the sac 10. The trans-sac procedure, often performedlaparoscopically, introduces the sac filler through a puncture in thewall 6 of the aneurysm, as shown by arrows 20. The endoluminal procedureintroduces the sac filler through the vessel that has the aneurysm 4, asshown by arrows 22, but within the space between the prosthesis and thevessel wall. The trans-graft, trans-collateral and endoluminalprocedures are often performed as minimally invasive, entirelyendovascular procedures.

It is desirable for a stabilizing element or sac filler to conform tothe available space within the sac 10 by operation of the geometry ofthe device (e.g., by nesting or coiling) and/or by any coatings ormaterials utilized to promote fusing or other coagulative effect.

U.S. Pat. No. 6,146,373 to Cragg et al. discloses a catheter system andmethod for injecting a liquid embolic composition and a solidificationagent directly into a sac. Cragg et al. teach the use of organicsolvents such as DMSO, ethanol and others injected directly in theaneurysm. Cragg et al. teach that these solvents can be toxic to tissueand may cause vascular spasms. Using liquid-solidifying agents in activevessels also carries a high risk that the agents will flow downstreamcreating emboli or flow into collateral vessels (e.g., lumbar arteries),which may lead to paralysis or other adverse events.

U.S. Pat. No. 4,994,069 to Ritchart et al., U.S. Pat. No. 5,133,731 toButler et al., U.S. Pat. No. 5,226,911 to Chee et al., and U.S. Pat. No.5,312,415 to Palermo disclose examples of thrombogenic microcoils,common aneurysm treatments. The microcoil must be tightly packed intothe aneurysm to minimize shifting of the microcoils. Shifting of themicrocoil can lead to recanalization of the aneurysm. Anotherdisadvantage of microcoils is that they are not easily retrievable. If acoil migrates out of the aneurysm, a second procedure to retrieve thecoil and move the coil back into place, or replace the coil, might benecessary.

U.S. Pat. Nos. 6,238,403 and 6,299,619, both to Greene, Jr. et al.,disclose an embolic device with expansible elements and methods forembolizing a target vascular site with the device. The device taught byGreene Jr. includes a plurality of highly-expansible elements disposedat spaced intervals along a filamentous carrier. The expansion of thedevice after deployment reduces the volumetric precision with which thesac can be filled. If the volume of the expanded device is too large,the device can press against the inner side of weakened aneurysm walland outer side of prosthesis, altering flow within the prosthesis andincreasing the risk of rupture of the aneurysm. If the volume of theexpanded device is too small, the prosthesis can still alter itsposition and dislodge or migrate.

There is thus a need for a device and method that can precisely occludea known sac volume with minimal displacement of the device over time.There is also a need for a device that can be deployed to the sac 10while simultaneously minimizing toxicity, embolism risk, and otherdisadvantages previously associated with existing aneurysm sac fillers.

BRIEF SUMMARY OF THE INVENTION

One embodiment of the disclosed device is a vascular embolization devicehaving a flexible leader connected to at least one non-expandable,space-occupying element. The elements can be made, for example, fromcollagen and/or a polymer such as polypropylene. The device can alsohave a radiopaque agent fixed to or integrated with the device.Furthermore, the device can be coated or infused with a therapeuticand/or diagnostic agent.

Another embodiment of the disclosed device is a vascular embolizationdevice having a leader made from a flexible material and aspace-occupying element connected to the leader. The element has a firstcomponent secured to a second component. The element can also beslidably connected to the leader, for example, by a ferrule.

Yet another embodiment of the disclosed device is a vascularembolization device having one or more cylindrical space-occupyingelements connected by flexible helical segments. When fully extended,the element has a cross-sectional width to cross-sectional height ratioof equal to or greater than about 1.5:1. The cross-sectionalwidth-to-height ratio can also be equal to or greater than 4:1.

A further embodiment of the disclosed device is a vascular embolizationdevice having a first space-occupying element having a first maleinterference-fit piece, and a second space-occupying element having afirst female interference-fit piece. The first male interference-fitpiece and the first female interference-fit piece attach to impederemoval of the first male interference-fit piece from the first femaleinterference-fit piece.

Yet another embodiment of the disclosed device is a vascularembolization device. The device has a first space-occupying elementcomprising a body and a first female interference-fit piece. The devicealso has a second space-occupying element comprising a body and a secondfemale interference-fit piece. Furthermore, the device has a leadercomprising a first male interference-fit piece on a first end and asecond male interference-fit piece on a second end. The first maleinterference-fit piece attaches to the first female interference-fitpiece attach and the second male interference-fit piece attaches to thesecond female interference-fit piece.

A method is also disclosed for placing a space-occupying device or aplurality of space-occupying devices, such as the embolization devicesdisclosed herein, within a void. For example, a catheter having a distalexit is placed at a vascular site. A vascular embolization device isthen passed through the catheter and the distal exit and deployed intothe vascular site. The device has a flexible leader and at least onenon-expandable, space-occupying elements connected to the leader. Themethod can include selecting a device or devices having the propervolume so that the device(s) is large enough to substantially fill thevoid, such as an aneurysmal sac within the vasculature, yet small enoughto prevent substantial alteration of the natural fluid flow through anadjacent element, for example a vascular prosthesis implanted at or nearthe vascular site. Furthermore, the method of the present invention mayprovide for the removal of material within the void, such as the removalof thrombus from the aneurysmal sac and treatment with therapeuticagents prior to, or in conjunction with, the placement of thespace-occupying elements.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 not the invention, illustrates an aneurysm.

FIG. 2 not the invention, illustrates a vascular prosthesis implantedwithin an aneurysm and procedures for filling the aneurysm sac.

FIG. 3a illustrates an embodiment of the embolization device.

FIG. 3b illustrates a portion of the embolization device of FIG. 3 a.

FIG. 4 is a cross-sectional view of an embodiment of the leader and thespace-occupying element.

FIG. 5 illustrates an embodiment of the leader and the space-occupyingelement of FIG. 4.

FIG. 6 illustrates an embodiment of the first section of thespace-occupying element.

FIG. 7 illustrates an embodiment of the space-occupying element of FIG.6.

FIG. 8 illustrates an embodiment of the first section of thespace-occupying element.

FIG. 9 illustrates an embodiment of the space-occupying element of FIG.8.

FIGS. 10 and 11 illustrate segments of embodiments of the embolizationdevice.

FIGS. 12a-c and 13 illustrate embodiments of the embolization device.

FIG. 14 illustrates a segment of an embodiment of the embolizationdevice.

FIG. 15 illustrates an embodiment of the method of implanting theembolization device.

FIG. 16 is a cut-away view of a catheter carrying an embodiment of theembolization device.

FIGS. 17 and 18 illustrate embodiments for the drivers used to deploythe embolization device.

FIG. 19 illustrates an embodiment of the slider from the driver.

FIG. 20 illustrates an embodiment of the connector.

FIG. 21 illustrates an embodiment of the connector in an unlockedconfiguration.

FIG. 22 is a cross-sectional view of the connector of FIG. 21.

FIG. 23 illustrates the connector of FIG. 21 in a locked configuration.

FIG. 24 is a cross-sectional view of the connector of FIG. 23.

DETAILED DESCRIPTION

FIG. 3a illustrates an embodiment of a vascular embolization orocclusion device 24 having a flexible leader 26 that can be connected toa first non-expandable space-occupying element 28 and a secondnon-expandable space-occupying element 30. Additional non-expandablespace-occupying elements 32 can also be connected to the leader 26 andprovided in various lengths, depending on the typical volume of the sac10 to be filled. The leader 26 can pass through the elements 28, 30 and32. The leader 26 can be fixed to the elements 28, 30 and 32, or theelements 28, 30 and 32 can slide freely over the leader 26. Asillustrated in FIG. 3b , the leader 26, even if secured within anelement 28, 30, or 32, can flex and bend within each element 28, 30 or32, or between the elements 28, 30 and 32.

The leader 26 can be a suture, preformed resilient structure, poppet,wire, fiber, monofilament, rail, or a woven thread or other combinationthereof. The leader 26 can be completely separate and discrete from theelements 28, 30 and 32. The leader 26 can be made from polymer, forexample polyester (e.g., DACRON® from E. I. du Pont de Nemours andCompany, Wilmington, Del.), polypropylene, polytetrafluoroethylene(PTFE), expanded PTFE (ePTFE), nylon, extruded collagen, silicone andcombinations thereof. The leader 26 can have a leader diameter 34 fromabout 0.050 mm (0.0020 in.) to about 1.3 mm (0.050 in.), more narrowlyfrom about 0.2 mm (0.006 in.) to about 0.25 mm (0.010 in.). A leaderspan 36 between the elements 28 and 30 can be from about 0 to about 2times an element outer diameter 38, more narrowly from about 0.5 toabout 1 time the element outer diameter 38. A total device length 40from one end of the device 24 to the other can be any length desired,for example about 30 cm (1 ft.).

The elements 28, 30 and 32 can be spherical, cylindrical, or anapproximation thereof. The elements 28, 30 and 32 can be made from anyof the materials disclosed above for the leader 26 as well as collagen,glass, polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA),polyglycolic acid (PGA), other bioabsorbable material, polyurethane,polyethylene, or metal, for example stainless steel, titanium ornitinol. The element outer diameter 38 can be more than about 0.1 mm(0.005 in.) of the leader diameter 34. The element outer diameter 38 canbe larger than about 0.25 mm (0.010 in.) less than an inner diameter ofa catheter through which the device 24 is deployed. The element outerdiameter 38 can also be larger than about 2.0 mm (0.079 in.), morenarrowly larger than about 2.7 mm (0.11 in.). An element length 42 canbe in the aforementioned ranges for the element outer diameter 38.

A device volume can be determined by calculating the total volume of theelements 28, 30 and 32 added to the total volume of the leaders 26. Ifthe leader 26 or the elements 28, 30 and 32 are made from bioabsorbablematerials, the reduction of device volume over time can be accounted forwhen calculating device volume. The device volume can be from about 20cc (1.2 in.³) to about 200 cc (12.2 in.³), more narrowly from about 60cc (3.7 in.³) to about 100 cc (6.1 in.³).

FIGS. 4 and 5 illustrate an embodiment of the element 28 with the leader26. The elements 30 and 32 can have embodiments identical to the element28. The element 28 can be made from a first section 44 and a secondsection 46. The first section 44 can be secured to the second section46. The sections 44 and 46 can have a section body 48 and an outer layer50. The section body 48 can be solid, solid with one or more dimples orchannels, or hollow. The outer layer 50 can be a porous membrane or havemacroscopic holes or channels that are in communication with the sectionbody 48. The element 28 can have one or more leader channels 52 havingleader channel diameters 54 about equal to or greater than the leaderdiameter 34. The leader channels 52 can be fixed to the leader 26.Alternatively, the leader 26 can have a clearance with the leaderchannels 52. A ferrule 56 can be fixed to the leader 26. The ferrule 56can be locked with an interference fit into a ferrule cavity 58.

FIGS. 6 and 7 illustrate an embodiment of the first section 44 and theelement 28, respectively. FIGS. 8 and 9 illustrate another embodiment ofthe first section 44 and the element 28, respectively. In theembodiments shown in FIGS. 6-9, the sections 44 and 46 can beidentically shaped. In the embodiments in FIGS. 4-7, the sections 44 and46 can be shaped to fit the opposite section 44 or 46 and form aninterference fit, for example a snap lock, with the opposite section 44or 46. The interference fit minimizes movement of the sections 44 and 46with respect to each other in any direction. In the embodiments in FIGS.8 and 9, the sections 44 and 46 can be shaped to fit the oppositesection 44 or 46 and form an interference fit that allows movement ofthe sections 44 and 46 with respect to each other in one translationaldirection.

FIG. 10 illustrates a segment of an embodiment of the device 24 with theleaders 26 having first ends 60 and second ends 62 that can beintegrated and conjoined segments of the elements 28, 30 and 32. Theleaders 26 can be preformed resilient structures formed into helicalshapes. The device 24 can be made entirely from the leader 26 andwithout elements 28, 30 and 32, as illustrated in FIG. 11, or eachelement 28, 30 or 32 can be separated from the adjacent elements 28, 30and 32 by as few as about 0.5 turns of the leader 26. More narrowly,each element 28, 30 or 32 can be separated from the adjacent elements28, 30 and 32 by from about 2 turns to about 3 turns of the leader 26.The leaders 26 can have a preformed leader depth 64 from about 0.25 mm(0.0098 in.) to about 2.0 mm (0.079 in.), more narrowly from about 0.5mm (0.02 in.) to about 1.0 mm (0.039 in.), and a preformed leader width66 from about 0.5 mm (0.02 in.) to about 4.0 mm (0.16 in.), morenarrowly from about 1.0 mm (0.039 in.) to about 2.0 mm (0.079 in.). Theleaders 26 can also have wind lengths 68. The wind lengths 68 can be thelongitudinal component of the length covered by about 360 degrees ofhelical turn in the element 28, 30 or 32. The wind lengths 68 can beabout 2.0 mm (0.079 in.). The wind lengths 68 can also vary within asingle element 28, 30 or 32, and five wind lengths 68 can be about 1.0cm (0.39 in.).

The device 24 can be structurally reinforced. For example, a structuralreinforcement 70 can be integrated onto the surface or encased by theleader 26 and/or the elements 28, 30, and 32. The reinforcement can be apolyester weave, or a coil or spiral element, for example a continuouswire wound within the device 24 such that the reinforcement 70 parallelsthe coils or helical shapes of the conjoined elements 28, 30 and 32 ofthe device 24.

In other embodiments of the device 24 illustrated in FIGS. 12a-c , theleaders 26 can have a male interference-fit piece, for example brads orpoppets 72, on a first end 60 of the leaders 26. The second ends 62 ofthe leaders 26 can be integrated and conjoined with the elements 28, 30and 32. The elements 28, 30 and 32 can have female interference-fitpieces, for example plugs or sockets 74, integrated into the elements28, 30 and 32 at the opposite ends of the elements 28, 30 and 32 fromthe poppets 74. The poppets 72 and sockets 74 can be shaped and sized toattach to each other with a sufficient interference fit to impederemoval of the poppets 72 from the sockets 74. The elements 28 and 30 atopen ends 76 of the device 24 do not attach to a neighboring element 28,30 and 32. The elements 28 and 30 at the open ends 76 can lack thepoppet 72 or the socket 74 on the open ends 76 of the elements 28 and30.

In another embodiment of the device 24 illustrated in FIG. 13, the firstend 60 of the leader 26 can have a first male interference-fit piece,for example a first poppet 72 a, and the second end 62 of the leader 26can have a second male interference-fit piece, for example a secondpoppet 72 b. A leader with male interference-fit pieces at two ends canbe called a “dogbone”. The elements 28, 30 and 32 can have two femaleinterference-fit pieces, for example sockets 74, integrated intoopposite ends of each element 28, 30 and 32.

FIG. 14 illustrates a segment of an embodiment of the device 24 havingfirst leaders 26 a with ends 60 and 62 that can be integrated andconjoined segments of the elements 28 and 30 and a second leader 26 bthat can pass through the first leaders 26 a and the elements 28 and 30.The second leader 26 b can have an interference fit at one open end 76,for example a knot 78. The second leader 26 b can be fixed or slidablyattached to the elements 28 and 30.

Radiopaque materials known to one having ordinary skill in the art canbe used anywhere in or on the device 24. Examples of radiopaquematerials are barium, sulfate, titanium, stainless steel,nickel-titanium alloys (e.g., NiTi), and gold. The ferrule 56 can bemade from radiopaque materials. A radiopaque patch or contrast agent canalso be integrated into or placed on the leader 26 or the elements 28,30, and 32. The contrast agent can be permanent or can be adapted toextravagate over time post-implantation. A radiopaque fiber can be woundintegrally with the leader 26. The radiopaque element can be present ina quantity sufficient to allow the operator to view deployment of thedevice 24 upon delivery, but not sufficient to obstruct thevisualization of adjacent tissues and structures post-implantation. Forexample, upon deployment, the operator can visualize the initialplacement and nesting of the elements 28, 29 and 30 and/or the leader26, but post-implantation the visualization of the prosthesis 8 can beunobstructed by the radiopaque nature of the elements 28, 29 and 30and/or the leader 26

The elements 28, 30 or 32 can be filled or coated with an agent deliverymatrix known to one having ordinary skill in the art and/or atherapeutic and/or diagnostic agent. The device 24, or any of the partsof the device 24, can be coated with the agents. These agents caninclude radioactive materials; radiopaque materials, for example gold;thrombogenic agents, for example polyurethane, cellulose acetate polymermixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious,hydrophilic materials; phosphor cholene; anti-inflammatory agents, forexample non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 inHypoxic Vascular Endothelium, J. Biological Chemistry 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties. Once the device 24 is deployed, these agents can providevarious benefits such as i) promote fusing of the space-occupyingelements 28, 30 or 32 to each other or to the surrounding biologicmaterials (e.g., a collagen coating), and/or ii) promote a thrombogenicresponse within the sac 10 to stabilize the device 24 and the prosthesis8, and/or iii) function to promote healing of the aneurysm at thecellular level such as in the case of treating an inflammatory response.

Method of Making

The elements 28, 30 and 32 and the leader 26 can be made from methodsknown to those having ordinary skill in the art. For example, theelements 28, 30 and 32 can be molded or machined. The embodiments of thedevice 24 illustrated in FIGS. 10, 11 and 14 can be extruded and then ahelical cut in the extrusion can be made by a blade, laser, water jet orhot wire to form the leaders 26 and 26 a.

The elements 28, 30 and 32 can be molded, machined, or mounted onto theleader 26. The elements 28, 30 and 32 can be mounted to the leader 26with an interference fit, for example by tying knots in the leader 26surrounding the elements 28, 30 and 32 mounting the elements 28, 30 and32 onto the ferrule 56 which is already crimped onto the leader 26. Theelements 28, 30 and 32 can be pressure fitted onto the leader 26, forexample by crimping the elements 28, 30 and 32 onto the leader 26,snapping snap-together sections 44 and 46 onto the leader 26, ordistortion mounting by heating the elements 28, 30 and 32 to a thresholdof thermal distortion. The elements 28, 30 and 32 can be glued onto theleader 26 with a biocompatible adhesive (e.g., cyanoacrylate); bondedultrasonically; or heat bonded (e.g., melting, heat welding). Eachsection 44 or 46 can be attached to the other section 44 or 46 with anyof the above methods.

Any part of the device 24, or the device 24 as a whole after assembly,can be coated by dip-coating or spray-coating methods known to onehaving ordinary skill in the art. One example of a method used to coat amedical device for vascular use is provided in U.S. Pat. No. 6,358,556by Ding et al. and hereby incorporated by reference in its entirety.Time release coating methods known to one having ordinary skill in theart can also be used to delay the release of an agent in the coating,for example inclusion of a collagen matrix in the coating.

Method of Use

Before using the device 24, the sac 10 can be cleaned of debris (e.g.,thrombi), for example by mechanically macerating the debris or using alytic agent (e.g., Urokinase, for example Abbokinase® from AbbottLaboratories, Abbott Park, Ill.). Examples of devices capable ofperforming pharmomechanical treatment—that can be delivered to the sac10 through the same delivery apparatus as the device 24—are the TRELLIS™and FINO™ from Bacchus Vascular, Inc. (Santa Clara, Calif.). Use of thedevice 24 can be performed while using a visualization tool, for examplefluoroscopy or computed tomography (CT) scanning. The volume of the sac10 not filled by debris can be estimated from visual inspection, forexample by inspection of images from the visualization tool. Softwareknown to one having ordinary skill in the art can also be used to assistin estimating the volume of the sac 10.

A length of the device 24 can be stored in a sterile package, forexample by an individual predetermined length or on a spool, spindle, orin a cartridge. The device volume can be reduced by removing more thanenough of the device 24 from the sterile package and then reducing thelength of the device 24, for example by cutting the leader 26 orunplugging a poppet 72 from a socket 74. In this way, the device volumecan be reduced to the approximate volume of the sac 10 not filled bydebris. The device volume can be large enough to substantially fill thevascular site, and the device volume can be small enough to preventsubstantial alteration of the natural fluid flow through the prosthesis8.

The device 24 can be deployed to the sac 10 using a trans-graft,trans-collateral, trans-sac, or endoluminal procedure. As illustrated inFIG. 15, a catheter 80 with a distal exit 82 can be placed in theaneurysm 4. The distal exit can be placed at the sac 10. The device 24can then be passed through the catheter 80 and distal exit 82, and canbe deployed into the sac 10.

As illustrated in FIG. 16, a catheter clearance 84 is the distancebetween the device 24 and an inner wall 86 of the catheter 80. The innerwalls 86 of the catheter 80 can act as a guide for the device 24 duringdeployment. If the catheter clearance 84 is too large, the inner walls86 of the catheter 80 can no longer act as a guide and the device 24 can“boxcar” within the catheter 80. Boxcarring occurs when the elements 28,30 and 32 bunch up and impair delivery, preventing an upstream elementfrom transmitting force to a downstream element in a directionsubstantially parallel with the inner walls 86. The maximum catheterclearance 84 before the elements 28, 30 and 32 can begin to boxcar isthe “critical clearance”. The critical clearance can be about 80% of theelement outer diameter 38, more narrowly about 26% of the element outerdiameter, yet more narrowly about 12% of the element outer diameter 38.

An end of the catheter 80 can have a valve 87 to minimize or completelyprevent backflow of body fluids or other leakage and improve theconnection of other devices to the end of the catheter 80. Use of thevalve 87 at the end of the catheter 80 is understood to one havingordinary skill in the art. The valve 87 can be, for example, ahemostasis valve (e.g., from Cook, Inc., Bloomington, Ind.).

FIG. 17 illustrates a ratcheting driver 88 having a feed tube 90 thatcan be used to control the device 24 during deployment. The device 24can pass through a channel 92 in the feed tube 90. An end 94 of the feedtube 90 can connect to the valve 87 or the catheter 80. The driver 88can have a spring-loaded handle 96. The handle 96 can be connected to aram 98. The handle 96 can move along a track 100 in the feed tube 90.When the handle 96 is pushed, the ram 98 can press the device 24 forwardthrough the channel 92. When the handle 96 is released, the handle 96can revert to a starting position and prevent the device 24 from movingbackwards through the channel 92.

FIG. 18 illustrates a sliding driver 88 having a slider 102. The slider102, illustrated in FIG. 19, can have a rib 104 that can engage thetrack 100. The slider 102 can abut and deliver a force to the end of thedevice 24 when the device 24 is in the channel 92.

The geometries of the elements 28, 30 and 32 of the device 24 and theproperties of the leader 26 can benefit delivery of the device 24. Asthe slider 102 delivers force to the end of the device 24, the leader 26can buckle or flex, allowing elements 28, 30 and 32 to approximate andtransmit force from one element 28, 30 or 32 to the other elements 28,30 or 32, thereby giving the device 24 sufficient column strength tomove through the channel 92.

As illustrated in FIG. 20, a connector 106 at the end 94 of the feedtube 90 can have a lipped hub 108 and a collar 110. The lipped hub 108can feed into the valve 87 or the opening of a channel in the catheter80. The collar 110 can fit over the valve 87 or the end of the catheter80 that joins with the feed tube 90, or the collar 110 can join withanother intermediary device between the catheter 80 or the valve 87 andthe feed tube 90. The connector 106 can have a check port 112 in thecollar 110.

FIGS. 21-24 illustrate an embodiment of the connector 106 that can lockto, and unlock from, the catheter 80. A first end of the connector 106can have a latch 114 that can form a friction or interference fit withthe valve 87 or the catheter 80 (not shown) when the valve 87 or thecatheter 80 is loaded into the collar 110 past the latches 114. Thelatches 114 can be rigidly attached to lever arms 116. The lever arms116 can be attached to the connector 106 at an attachment location 118so that the position of the lever arms 114 forces the latches 114 toform the friction or interference fit with the valve 87 or the catheter80 when no external forces are applied to the lever arms 116. A secondend of the lever arm 116 can also have a press tab or button 120.

When a force (shown by arrows in FIG. 22) is applied to the buttons 120,the lever arms 116 can rotate around the attachment location 118,removing the friction or interference fit between the latches 114 andthe valve 87 or the catheter 80.

The connector 106 can have a lock 122 that can be rotatably attached tothe remainder of the connector 106. Tabs 124 can protrude from the lock122. The tabs 124 can be used to aid rotation (shown by arrows in FIGS.21 and 23) of the lock 122 relative to the remainder of the connector106, and to provide an interference fit to prevent the lock 122 fromturning from one lever arm 114 past the next lever arm 114. The lock 122can have a thick portion 126 and a thin portion 128.

The lock 122 can be rotated to position the thick portion 126 betweenthe lever arms 116 and a retaining wall 130 (shown in FIGS. 23 and 24),minimizing the rotation of the lever arms 116 and preventing the removalof the friction or interference fit between the latches 114 and thevalve 87 or the catheter 80. With the lock 122 in this position, thevalve 87 or the catheter 80 can be locked to the connector 106.

The lock 122 can be rotated to position the thin portion 128 between thelever arms 116 and the retaining wall 130 (shown in FIGS. 21 and 22),allowing substantially free rotation of the lever arms 116 and enablingremoval of the friction or interference fit between the latches 114 andthe valve 87 or the catheter 80. With the lock 122 in this position, thevalve 87 or the catheter 80 can be unlocked and removed from theconnector 106.

The driver 88 can be integrated with the sterile package (e.g.,individual predetermined length, spool, spindle, or cartridge) loadedwith the device 24. A new package loaded with the device 24 can replaceor be swapped for an old package at the connector 106.

The device 24 can be visualized by the visualization tool before, duringand after the device 24 has been deployed. After the device 24 has beendeployed, any agents in or on the device 24 can elute into the tissueand fluids. The vascular prosthetic 8 can be implanted before, during orafter the device 24 is deployed.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention.

We claim:
 1. A system for treating an aneurysm comprising: a catheter having a distal exit having a deployed configuration and an undeployed configuration; and a self-fusing material, wherein when the self-fusing material is in the undeployed configuration, the distal exit is placed between an outer surface of a prosthesis and a wall of the aneurysm, and the self-fusing material is in the catheter, wherein when the self-fusing material is in a deployed configuration, the self-fusing material is in the space between the outer surface of the prosthesis and the wall of the aneurysm, and the self-fusing material has fused to itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material and the prosthesis, wherein the self-fusing material is configured to promote fusing or other coagulative effect, and wherein the self-fusing material is radiopaque such that in the deployed configuration, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.
 2. The system of claim 1, wherein the self-fusing material comprises a polymer formulation.
 3. The system of claim 1, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.
 4. The system of claim 1, further comprising a visualization tool for visualizing the self-fusing material before, during, and after the self-fusing material has been deployed.
 5. The system of claim 1, wherein the self-fusing material comprises a coating, wherein the coating is an agent, and wherein the agent is at least one of a therapeutic agent and a diagnostic agent.
 6. A system for treating an aneurysm comprising: a catheter having a distal exit having a deployed configuration and an undeployed configuration; and a self-fusing material, wherein when the self-fusing material is in an undeployed configuration, the distal exit is placed between an outer surface of a prosthesis and a wall of the aneurysm, and the self-fusing material is in the catheter, wherein when the self-fusing material is in a deployed configuration, the self-fusing material is in the space of the aneurysm, and the self-fusing material has fused to itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material, wherein the self-fusing material is configured to promote fusing or other coagulative effect, and wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.
 7. The system of claim 6, wherein the self-fusing material comprises a polymer formulation.
 8. The system of claim 6, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.
 9. The system of claim 6, further comprising a visualization tool that can visualize the self-fusing material before, during, and after the self-fusing material has been deployed.
 10. A method for treating an aneurysm comprising: placing a distal exit of a catheter between an outer surface of a prosthesis and a wall of the aneurysm; and deploying a self-fusing material through the distal exit of the catheter; wherein after the self-fusing material is fully deployed from the catheter, the self-fusing material fuses with itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material, wherein the self-fusing material is configured to promote fusing or other coagulative effect, and wherein the self-fusing material is radiopaque such that in the deployed configuration, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.
 11. The method of claim 10, wherein the self-fusing material comprises a polymer formulation.
 12. The method of claim 10, wherein the self-fusing material is deployed within the space of the aneurysm using a trans-graft, trans-collateral, trans-sac, or endoluminal procedure.
 13. The method of claim 10, further comprising visualizing an initial placement and nesting of the self-fusing material prior to and during deployment with a visualization tool.
 14. The method of claim 10, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.
 15. The method of claim 10, wherein placing the distal exit of the catheter between the outer surface of the prosthesis and the wall of the aneurysm comprises placing the distal exit of the catheter within a space of the aneurysm, wherein the space of the aneurysm is between the outer surface of the prosthesis and the wall of the aneurysm.
 16. The method of claim 15, wherein the self-fusing material is radiopaque such that after the self-fusing material has been deployed, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.
 17. The method of claim 15, further comprising selecting the self-fusing material having a proper volume so that the self-fusing material is large enough to substantially fill a void in the aneurysm, yet small enough to prevent substantial alteration of a natural fluid flow through the prosthesis.
 18. The method of claim 15, wherein the self-fusing material is deployed between the outer surface of the prosthesis and the wall of the aneurysm using a trans-graft, trans-collateral, trans-sac, or endoluminal procedure.
 19. The method of claim 15, wherein the self-fusing material comprises a polymer formulation.
 20. The method of claim 10, further comprising visualizing the self-fusing material before, during, and after the self-fusing material has been deployed. 